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Apr 01, 2020
Taking a Risk-Based Strategy Further: It’s Time to Rethink Clinical Trial Monitoring
There probably isn’t a person on this planet that isn’t closely watching the current coronavirus (COVID-19) pandemic. Like everyone, I am concerned with the health of my family, our employees, our customers, and generally the people of the world impacted by this virus. But it is in the face of such adversity that we need to ask how we can adapt for whatever uncertainty the future holds. If anything is certain, it is that there will be circumstances that will disrupt business as usual. Disruption happens. Businesses need to be prepared for these disruptions and many have business continuity strategies currently in place. But, who could have predicted a global pandemic which has impacted every business sector and supply chain? Answer: No one. Clinical trials are vital for evaluating and advancing medical and patient care. Today’s current situation is impacting how these clinical trials can continue operating safely and efficiently. Functions impacted include – but are not limited to – supply chain, patient safety, data integrity, patient retention, investigational product management, clinical trial monitoring and trial management in general. All areas in clinical trial management have been impacted but specific to clinical trial monitoring, the current model must be modified to ensure that the clinical trials can continue to operate. Specifically, clinical trial monitoring must be adapted to ensure a risk-based strategy is implemented to manage all study-related risks but also to ensure that patient safety is addressed and that data integrity is maintained. Here are a few observations in the current clinical trial monitoring model that need to be reconsidered in light of our current situation: Clinical trial monitoring is primarily based on physical movement of people. CRAs are moving from site to site. You only need a few flight disruptions and cancellations to cause issues. And now, CRAs are likely not able to perform site visits due the coronavirus restrictions. It can be retrospective and reactive. CRAs can only be at one place at a time. As a result, there is no real-time detection of site related issues. It might not be until the next site visit weeks later that potential risks are identified. It can separate research staff and critical medical/scientific knowledge. In most instances, the CRAs are the intermediaries between research staff and trial management and medical monitors. This “switchboard” means providing study related answers can take precious time that no one can afford. In the current environment, quick and real-time communication is essential to ensure continuity of care. It is dependent on paper. This requires that site staff physically refer to the regulatory binder for protocol-specific information. How will regulatory documents be accessed for verification if CRAs or site staff are not physically located on site? Specifically related to the protocol for quick reference, how will sites be ensured that they are utilizing the most current version available? In consideration of the current circumstances and to bring us forward in confronting the current monitoring limitations, it is time to rethink the approach to monitoring and bring it into the 21st Century. We can help. Here are some targeted solutions that I think can realistically improve the effectiveness of monitoring and address the inevitability of disruptions that will happen in the future: Rely less on face-to-face interactions. Utilizing a risk-based approach, CRAs will only be on-site to address any critical milestones and will have more time and bandwidth to assess critical to quality endpoints in-house rather than onsite. Streamline communication with research sites. CRAs and clinical trial management should have a proactive, simple and streamlined way to provide real-time updates rather than generic or passive means (e.g. in person visits, email, newsletters, etc.). This includes proactive information on study updates as well as answers to time sensitive questions. Measure the impact of the communication. Hope isn’t a strategy. When it comes to knowing whether study-related information has been effectively delivered and received and being actioned by the target audience, there is no room for guessing whether the PI or study coordinator got the message. Respond quickly to data that shows potential risk to the study. With less physical travel, CRAs can review data remotely in real time and respond to critical data points that are negatively trending and represent a risk to the study. In this model, we can further improve the quality of the trials and better protect patient safety. Have immediate access to the current protocol any time. Research staff and CRAs always need access to the right version of the protocol at their fingertips. This isn’t always practical or efficient with paper or PDFs in a portal. But real-time access to the right version at the right time is vital. Out of any crisis, there is an opportunity to reflect on how we can better prepare for the future. We’ve seen how important it is to continually evaluate new ways of operating in light of this current situation. With the management of clinical trials, there are numerous strategies to be considered. Specific to monitoring clinical trials, it’s time to rethink the current model. Fortunately, with the smart use of technology, it is not out of reach to make changes in how clinical trials are monitored and we are well-positioned to rise up and meet the challenges imposed by COVID-19 and its impact to the management of clinical trials. What do you think about modernizing clinical trial monitoring? Please send me your thoughts at connectwithandrea@teckro.com
Blog
Mar 24, 2020
A Letter from Our CEO: Supporting Your Clinical Trials Without Interruption During COVID-19 Crisis
I would like to assure all of our clients that Teckro is well prepared to support your clinical trials, in spite of the COVID-19 pandemic. I understand that you are challenged with restricted movement of CRAs and patients, and that research staff are under pressure to treat those afflicted with the coronavirus (COVID-19). You can be rest assured that Teckro will do everything in our power to support your trials without interruption. Whether you have protocol amendments, need to change user access, or have users who need support from our helpdesk, our staff will be available. At Teckro, we have reviewed our existing pandemic plan, and we are updating as necessary. Like everyone, we are closely monitoring advice from local health and government authorities in all of the countries where we have staff. We have a dedicated task force that meets daily to plan and assign actions and to keep senior leadership current on any developments.   As with many businesses, we have taken the precaution to suspend all non-essential travel. Our global staff are working remotely from their homes until April 10, at which point we will reassess the situation. To preserve business continuity, we have core teams identified as well as second-in-command personnel for major functions, should the need arise.  From a product standpoint, Teckro software is built on a hybrid infrastructure between top-tier Equinix data center and AWS. Our Equinix-based infrastructure is fully redundant on each layer starting from power, connectivity, and throughout the application and database layers. Our AWS-based infrastructure is deployed across three availability zones for high redundancy. Teckro has robust DR procedures to allow a move from Equinix to AWS as required, which is tested on a regular basis. This is a global crisis that knows no boundaries of nations, races or beliefs. United as one, we will overcome this situation. I hope that you, your families and your employees stay in good health. If there is anything I or my staff can do to help you at this time, please don’t hesitate to contact us. Best regards, Gary This letter was originally published on March 12 and has been revised on March 24. Updates will be published here as necessary to provide current, ongoing information for our customers and business partners.
Blog
Mar 08, 2020
International Women’s Day 2020: We Must Demand More Gender Diversity in Clinical Trials
In the first of our series on clinical trials and diversity, our CEO Gary Hughes discussed how ethnic populations are underrepresented in trials, leading to a lack of knowledge around how drugs affect patient groups viewed as outside the “norm” (today still primarily white and male).  On International Women’s Day I’d like to draw attention to that other neglected cohort: women. As roughly 50% of the population, we’re hardly in the minority, which is why it’s so shocking that women’s health is so under-researched.  Women’s lack of participation in clinical trials is not a new problem. A recent study from the Allen Institute for Artificial Intelligence in Seattle examined women’s participation in medical research over a quarter of a century, looking at 13,000 trials registered on clinicaltrials.net. While women made up 49% of all participants, when the data was analysed study by study, women were often still unrepresented. For many disease types, the ratio of females to males didn’t match the real-world gender split among patients. This included deadly conditions such as cardiovascular disease and chronic kidney disease. 
Blog
Feb 28, 2020
We Cannot Afford to Ignore the Lack of Ethnic Diversity in Clinical Trials
The importance of diversity in clinical trials cannot be emphasized enough – yet progress isn’t being made nearly as quickly as needed. Recent research shows that the levels of patients enrolling in a clinical trial as a first form of treatment for cancer in the US is just 0.1% and this is predominantly made up of White men with private insurance. A ProPublica analysis found that in trials for 24 of the 31 cancer drugs approved since 2015, fewer than 5% of Black patients were enrolled. Yet, African Americans make up 13.4% of the US population. Sadly, these statistics don’t surprise me. Ethnic groups have been underrepresented for as long as I can remember. This is a huge problem. Drugs can work differently depending on factors like sex or ethnicity, meaning people from different ethnic groups and genders may respond in hugely different ways to the same drug. But if there’s a lack of diversity in clinical trials, how will we ever know? Stand Up to Cancer Moves to Make Trials More Diverse Here at Teckro, our machine learning platform is used by more than 7,000 oncology sites worldwide and I recently wrote about Teckro’s goal to revolutionize clinical trials to help beat cancer on World Cancer Day. Therefore, I welcomed the news that Stand Up To Cancer (SU2C) have announced a ground-breaking new initiative to increase ethnic representation in clinical trials. All future SU2C-supported grant proposals will now be required to address how the research will consider ethnic diversity when it comes to recruiting and retaining patients. The move comes just a few months after the FDA announced a new focus on enhancing clinical trial diversity. These bold new developments force us in the industry to adapt, learn best practices and work to ensure the clinical trial population is a true representation of society. After all, diversity is crucial for safer, more effective medicines, so that researchers, regulatory bodies and patients are confident that a drug or therapy will reach the communities they’ll serve best. Here are a few more suggestions I have to help make clinical trials more ethnically diverse: Make participation easier. Currently time and travel commitments mean that taking part in trials is difficult for participants. By making trials more accessible, it will be easier to recruit from a wider variety of backgrounds. By using digital and virtual clinical trials, patients located further afield could be reached and the burden could be minimized by conducting some aspects of the trial remotely. Wearables, smartphones and tablets could also make participation more convenient. Build trust. For more ethnic communities to be engaged in clinical research, there needs to be improved relationship building and a better sense of partnership. Patients need to trust the research process, as well as the healthcare professionals involved and – it should go without saying - be treated with respect for their role in the trial. This can be achieved by having specific teams from local communities onsite to understand cultural sensitivities. As a result, more diverse clinical research communities will be built, leading to a more varied pool of participants. Improve awareness. Many potential participants don’t even know that clinical trials exist! The research community could change this by reaching out to local physicians to increase awareness of clinical trials. Resources could be provided to help them discuss the benefits with patients. In my previous blogs, I’ve mentioned how important it is to make the clinical trial process more convenient for physicians. And because physicians are typically short on time, they may not even be that knowledgeable about clinical trials themselves. Which brings me on to my final point… Increase education. Driving better understanding of clinical trials is an essential element when it comes to participation from a wider group. Providing proper education (using culturally appropriate materials) is a way to assist further understanding. And this goes beyond physicians handing out a few leaflets, ideally there would be strong local publicity campaigns – even nationwide conversations about the importance of ethnic diversity in clinical trials. Ambitious? Definitely. But a future of safer drugs, more efficient medication and lives saved, is one worth fighting for. Do you have any further thoughts on advancing clinical trial diversity? I’d like to hear them, please email me: connectwithgary@teckro.com.
Press Coverage
Feb 27, 2020
What Does the Future Hold for Clinical Trial Recruitment?
Blog
Feb 04, 2020
World Cancer Day 2020: Progress Has Been Made - But We Can Do Better
World Cancer Day is a chance for global communities to unite, to show solidarity and pledge to work together to defeat this devastating disease. It’s also an opportunity to celebrate – we know more about cancer than ever before thanks to incredible breakthroughs in new medicines, advances in surgery and increasing scientific knowledge. The American Cancer Society has reported that cancer death rates in the United States alone fell 2.2% from 2016 to 2017 – that’s the largest single-year decline in cancer mortality ever reported. And cervical cancer could be eliminated by the end of this century, according to The Lancet, if cervical screening and HPV vaccination programs are scaled-up to 80% -100 % coverage over the next 50 years.  On one hand the decline can be linked to lifestyle changes, with smoking cessation contributing to the drop in the cancer mortality rate - lung cancer accounts for nearly one-quarter of all cancer deaths. But improved cancer detection tools such as new imaging technologies and less invasive surgical approaches have also played their roles. The official World Cancer Day site estimates that up to 3.7 million lives could be saved each year by mobilizing resources for prevention, early detection and treatment. Teckro’s Message on World Cancer Day, February 4, 2020  While we celebrate the breakthroughs made so far, the truth is that millions of people across the world will continue to die from cancer because new medicines are taking too long to get to market. Also, more than half of doctors who run their first clinical trials will never run another, meaning that patients’ access to trials are limited and therefore, so is the search for a cure. This is why our message on World Cancer Day 2020 is that we can do better. Much better. Clinical trials are stuck in another time, the burden on investigators and trial sites is increasing – which is quite extraordinary considering this technological era when we’re all so obsessed with speed and instant results! The cumbersome nature of the protocol puts physicians off participating and slows down progress when it comes to defeating serious diseases like cancer.  We’re proud that Teckro is leading the way in changing this reality. Our machine learning platform is currently being used to support more than 7,100 oncology research sites around the world. An impressive 77% percent of registered users are active on the platform ­– and it’s not required, so they are consciously choosing to use Teckro because the platform brings so much value to them.
Blog
Jan 28, 2020
Overcoming Fear of the Unknown: The Path to Virtual Clinical Trials
Recently, I attended a seminar on virtual clinical trials. I know, I know…another seminar to enlighten us on what’s new, upcoming, and trending. With benefits like reduced costs and saved time, virtual clinical trials seem appealing. So, why aren’t sponsor companies and clinical research organizations (CROs) running to implement them? Those of us who have worked in the pharma industry for quite some time understand that while new technology might sound promising, there are real challenges with its implementation. If we are being honest about why virtual clinical trials are not being implemented as quickly as you would expect, the truth – at least in part — is fear of the unknown. Let’s face it, trying to change years of clinical trial conduct is like turning the Titanic on a dime. Process changes, organizational mindset, regulatory requirements, data privacy concerns, and impacts on other internal systems are just a few reasons why virtual clinical trials haven’t taken off. So how do we challenge our current system and take that first step into this unknown space – or at the very least, dip our toes into the big scary pond that is virtual clinical trials? The bigger question in my mind is, can we as an industry afford not to? We only need to take a look at the current state of clinical research trials to see how broken they are. With an approximate 30% patient drop-out rate and 50% of sites not recruiting as per schedule, it’s clear we need to tackle the root causes for continuous trial delays. There is also a lack of trial diversity. Specifically, the women, elderly and individuals in rural populations who are woefully underrepresented. Throw in some additional barriers like patient mistrust making recruitment more difficult, and it’s not hard to see that we have a real problem. Given these glaring statistics, we need to ask how can virtual clinical trials improve the current state of the industry? There are instances where some are already dipping into the virtual clinical trial space, especially in late-phase trials. But we need a push to take the ultimate plunge within the Phase I-III space. That push is coming directly from the patients, and their voices are getting understandably louder. Let’s discuss removing these barriers to get into the virtual clinical trial game. Here are a few checklist suggestions to start the discussion: Take a holistic approach. Whatever technology is being considered must be harmonized across all devices. As an example, the smartphone plays an essential role. It can be used for patient engagement, medical reminders, phone/telemedicine options, patient eDiary, and follow-ups. Consider what data you need. An app alone can only solve one part of the problem. Data needs to be enabled within the app, which means the level of information captured is crucial. As an example, capture only what is vital for an endpoint of the study ­­– any additional information will complicate the study by requiring additional regulatory hurdles, incurring data reliability issues, data overload or resistance from patients and healthcare providers. Fit into the everyday life of the user. Technology should not be a burden for the patient or healthcare professional. For example, instead of having to manually track and enter data could the patient use a wearable device that would automatically and easily capture the required information? Plan for changes. Another consideration is to evaluate what would happen if there is a change in the technology itself. If there are routine software changes, will the data remain viable? Consider how this will be managed. Factor in compliance. Finally, compliance is key! Consider compliance with actually wearing the device or using the technology. Again, this needs to fit seamlessly into their day to day life. The good news is that sponsors and CROs don’t have to go it alone. There are existing resources out there that can offer assistance for evaluating new technology. And the FDA has existing guidance to help ensure the appropriate regulations are being followed. We are on the cusp of transforming how we conduct clinical trials. Yes, there are regulations and challenges, but even the FDA is on board and encouraging greater adoption of clinical tools. Our collective job now is to take the leap and be the innovative change agents that move the industry forward. Do you have any suggestions on how to improve industry adoption for modern technology like virtual clinical trials? Please email me at connectwithandrea@teckro.com.
Blog
Dec 18, 2019
The Secret to Clinical Trial Success: Unblocking Research Staff
There aren’t enough physicians in the world taking part in clinical trials. But what’s more troubling is that a large percentage of doctors who run their first clinical trial say they wouldn’t run a second one.  Physicians are the trusted advisor to patients. Without increased participation from them, it limits access to clinical trials for patients. Rather than trying to skirt the problem, we need to address core issues that limit why doctors don’t want to run clinical trials. Reducing Interaction Costs  Doctors generally have just a few minutes with each patient. This means they have a very short window to make critical decisions about the patient’s eligibility for a clinical trial. For larger research centers, this decision can be even more difficult if they are running several trials for different sponsors in the same disease area.  Given time pressures, logically speaking, it would make sense that doctors have quick and easy access to the information they need when they are with the patient.  Yet, access to the clinical trial protocol and other study documents today is primarily through binders of paper documents that are nowhere near the patient. Or, there may be electronic versions of the same documents that are hosted on a secure password-protected portal.  Neither approach is ideal for busy, time crunched research staff on the go. The reality is that high interaction costs – the time and effort to find answers – can limit trial success if it’s just too hard to find the information to make the right decisions.  Unblocking Research Sites Whether clarifying inclusion/exclusion criteria, managing a toxicity, or confirming the next steps from an adverse event, research staff will have questions that require input from experts. Sometimes the answers are time sensitive.  With so many channels – email, phone, text, chat – it’s hard to keep track for both CRAs and research staff. Email still seems to be the dominant channel, but it lacks any urgency for immediate questions.  Additionally, informing research staff of study or document changes is not straightforward as different sites may be on different versions of the protocol and located around the world. Newsletters are an effort to tackle some of the challenges, but that is still a generic, one-way broadcast. It is no surprise that communication is a common complaint among research staff. Without timely, accurate answers, sites are blocked. If sites are blocked, trials are blocked.   Considering the Research Site Viewpoint  Research staff have the best insights when it comes to patients. It is a wasted opportunity not giving them a voice with regards to things such as whether a trial should progress to the next phase or the viability of finding patients for a given study.  By asking for research site feedback, sponsors can gain valuable field-level intelligence that can influence trial success and future study design. Who better to give input than those who know the patients best?  Let’s not forget that investigators and research nurses are human. Asking for feedback has the potential for sponsors to foster better relationships with research staff. This in turn could make them the sponsor of choice and ensure that clinics want to manage their trials.  Giving Research Staff Confidence  It all comes down to confidence. Research staff need to have confidence they are making the best choices for their patients.  As the front line in any clinical trial, we need more doctors engaged. Giving them the tools they need to make informed decisions at each step could reduce friction for sites. And with more doctors participating, more patients will have the opportunity to participate in clinical trials.  This would be a win for everyone. Do you agree? Please let me know at connectwithgary@teckro.com.
Press Release
Nov 25, 2019
Teckro Adds New Products Following Sky-High User Adoption
Meet Teckro: the machine-learning platform revolutionizing the way clinical trials are run.
Press Coverage
Nov 21, 2019
Limerick-based Healthcare Startup Given Major Boost
Blog
Nov 19, 2019
The Trouble with Clinical Trials: Getting Rid of Zombies
New medicines are becoming increasingly complex to develop. As a result, clinical development is taking 25% longer and the chance of a new medicinal product getting market approval is half of what it was a decade ago. Much of this is reflected in the way clinical trials are performed, with a 10% annual increase in the number and variety of procedures required. Thus, the burden on investigators and trial sites is steadily becoming heavier. In most aspects of our lives, the internet has enabled us to rapidly access information. In particular, smartphones allow us to search and retrieve almost any information that we need “on the fly.” We book our flights and hotels, make restaurant reservations and communicate with our families on our phones. Who uses, or even possesses, a telephone directory anymore? However, a zombie-like relic of the telephone directory still lives on in clinical trials. It’s called the protocol, which: Is almost always a weighty document of perhaps 150 densely printed pages. Must only be used in its currently approved version, so it may need to be changed half a dozen times during the life of a trial. Each amendment must be approved for every individual site. Usually lives on a shelf in an office, often remote from where it is most needed in the clinical area in which its trial is being conducted. Is slow to search for information, especially if not immediately to hand. If it does have an electronic existence, it is usually as a PDF document which is hard to search in a hurry. The protocol hasn’t changed in any significant way for 40 years. It is no surprise that about 35% of adverse findings of FDA inspections are related to non-compliance with the protocol. This is not a harmless zombie! There are many examples to illustrate why printed protocols have outlived their utility. For example, typical oncology sites outside of the major centers may run about a dozen different trials at one time. It is a big ask to expect an investigator to remember the detailed inclusion and exclusion criteria for each one when they sit in-clinic seeing their patients. Their time constraints mean that they have only a few minutes to consider whether any patient in particular might qualify for one of these trials. They are unlikely to rummage through a dozen protocols to check. They may refer to a “cheat sheet” with the criteria listed. Are they sure it’s from the current protocol version? It’s easier to procrastinate and move along to the next patient waiting in line outside their office. Another possible trial participant misses out. Another example illustrates how adverse effects don’t respect office hours. Consider the following scenario. Its 8 p.m. on a Friday. A study coordinator in an Immuno-oncology study is about to sit down to dinner in a restaurant. A study participant phones urgently to report sudden onset bloody diarrhea and is desperate to know what to do. The protocol copy is two miles away. How will the coordinator instruct the participant exactly according to protocol? Do we expect them to recall precisely what the protocol says, or will they set off to consult it? Or will they just try to remember and hope that they are correct? It is vital that the right advice is given if the safety of the participant and the integrity of the trial are to be preserved. To effectively deal with the many weaknesses of relying on printed protocols that live on office shelves, we need to bring the whole process into the 21st century. Just as we have with almost all ways that we seek and find information in every other aspect of our lives. Do you have any other examples of how today’s paper protocol hinders clinical trial success? I’d like to hear them – you can email me at connectwithbrendan@teckro.com.
Blog
Nov 14, 2019
#WorldDiabetesDay: How Clinical Research Is Revolutionizing Diabetes Treatment
Someone dies from diabetes every 8 seconds. The number of adults with diabetes has doubled in the past three decades, according to the World Health Organization. On World Diabetes Day, we'd like to highlight the importance of clinical trials for diabetic patients. Clinical research has revolutionized the treatment of diabetes. Prior to 1921 diabetes was akin to a death sentence, until Banting and Best isolated insulin for injection. Originally extracted from cows and pigs, clinical researchers went on to develop synthetic insulin by modifying bacteria to mass-produce insulin in the lab during the 1980s. Clinical trials conducted during the 1950s gave us oral hypoglycemic agents for the treatment of type 2 diabetes. In recent years, there have been a number of exciting new developments in diabetes research: Glucose Monitoring Tattoos: Scientists at Harvard and MIT are currently exploring the possibility of using tattoos to detect changes in blood sugar, reducing the need for finger-prick tests. Traditional ink would be replaced by fluorescent biosensors that change color in response to high or low blood sugar. Insulin Patches: Recently, insulin patches for the treatment of diabetes have emerged from clinical trials. Insulin is delivered via a patch applied to the skin (like nicotine or contraceptive patches), removing the need to directly inject insulin. A recent study found that the patch is just as effective as insulin pens while providing a preferable delivery alternative for patients and clinicians. Light-Activated Insulin Producing Cells: Researchers at Tufts University have recently transplanted engineered beta cells (insulin-producing cells of the pancreas) into diabetic mice. When exposed to light, these cells produced 2x to 3x the normal amount of insulin, allowing glucose levels to be controlled without the need for drug intervention. New Drug Targets: Most recent of these innovations is the identification of the biological mechanism through which a rare mutation in the SLC30A8 gene can protect against the development of type 2 diabetes. This gene is involved in zinc transport in the body, which is important for insulin secretion. Now that we know how the mutation acts, this research potentially gives us a new target for future anti-diabetic and preventative therapies. As the exact cause of type 1 diabetes remains unknown, clinical research is vital. It will allow researchers to compare and contrast patient blood glucose levels, track metabolism, monitor organ functionality in relation to medications, shape the improvement of current treatments, bring new treatments to fruition, and perhaps one day, develop a cure. Have thoughts about how clinical trials can help with the treatment of diabetes? Please email connectwithaoife@teckro.com, I'd love to hear from you!
Blog
Nov 08, 2019
#STEMDay “Never Stop Being Curious”
The lack of women today in STEM (science, technology, engineering and mathematics) jobs is a problem. We believe with more role models and positive examples of women succeeding in technical roles, we can change this. To honor STEM Day, we spoke with Teckro Director of Clinical Operations Cayce Drobek about why she pursued a STEM career and her advice to encourage more girls into fields of science and technology. By way of background, Cayce studied at Middle Tennessee State University, graduating with a bachelor’s degree in mental health and biology. She went on to complete two master’s degrees, one in microbiology and a second in clinical research. Cayce has more than 12 years of professional experience in clinical research, working on numerous Phase I-IV trials. In addition, Cayce also worked with multiple contract research organizations (CROs) and investigative clinical trial sites, and she is a Certified Clinical Research Associate. Now, Cayce is applying her domain expertise at Teckro, where among other roles she has managed teams responsible for the quality and accuracy of the clinical research content in the product. Cayce, what first prompted you to go into a technical role? I have always been drawn towards science, math and technology. I have always been a very curious individual with a strong desire to constantly increase my knowledge. Even as a young child, I loved playing with my microscope and was always conducting experiments in the hope of making exciting new discoveries. I still love conducting experiments, trying new things, and making discoveries to solve everyday challenges in my personal and professional life. Because of my passion for science, I studied biology as an undergraduate, and then microbiology in graduate school.  While in school, I worked as a study coordinator for obstetrics and neonatology trials.  In this role, I experienced many of the common clinical trial challenges that site staff face every day. I ultimately developed and rolled out new processes at the research center with the help of technology to reduce some of the burdens on the staff. I’ve worked with multiple technology systems in my years in clinical research roles. While many of these technologies were aimed at reducing my day to day work-related burdens, there was still a need for simplification. This is Teckro’s mission, and I wanted to be a part of a solution that could really simplify how trials are conducted. Did you have any special encouragement, or role models when you started out? My mother is the primary reason for me pursuing a career in clinical research.  While I was in graduate school, she unfortunately was diagnosed with cancer. Caring for a loved one with cancer was extremely difficult. Thankfully, after participating in a clinical trial at Vanderbilt University Medical Center, my mother had complete remission. I was so grateful that she had this opportunity and I’m now extremely motivated and passionate about being a patient advocate. I work to make these types of clinical trial opportunities available not only for those who have cancer but for all types of diseases and disorders. What does a career in a STEM field mean to you? Science is not just a job; it is a passion. If your career is something you enjoy doing, you will lead a happier and more productive life. Working in a STEM field provides me with the thrill of new, exciting discoveries. It allows me to travel the world solving global challenges. It gives me broad, marketable skills. And I believe it increases my career opportunities, not just in biology or clinical trial-specific roles but in also roles for technology companies who need clinical trials subject matter experts. I’ve become a better problem solver and gained a better understanding of how things work. And not least of all, it’s fun! What advice would you give to young women considering a STEM career? Never stop being curious! For young women interested in pursuing a professional degree and career in a STEM field, I would recommend starting off by doing some independent research into what education and opportunities are available. You can also join organizations that advocate for girls and women in STEM, such as those listed on Girls Who STEM. One of my favorite quotes is from Mae Jemison, the first female African American astronaut to travel into space: "Don't let anyone rob you of your imagination, your creativity, or your curiosity. It's your place in the world; it's your life. Go on and do all you can with it, and make it the life you want to live.” We are naturally born with a desire to understand how and why things happen the way they do. This desire drives us towards science, which provides us the path to illumination of the many mysteries of the universe.
Blog
Oct 30, 2019
How to Effectively Engage Your Site Staff
At any clinical trial site, time is the most valued commodity for busy and over-burdened site staff. Communicating in a fast, effective way is key to sustaining a positive relationship with the team who is crucial in the successful delivery of your clinical trial. All of this is easier said than done, this is where site staff engagement becomes critical. What is site engagement? A good place to start is with the word engagement. This, by definition, is the creation of meaningful connections and interactions with people. Engagement is ensuring successful communication with trial sites and optimizing every interaction with your busy teams. Successful engagement should focus your awareness on an individual's behaviors and actions, based on who they are and what they do, allowing you to support them towards their goal. Who do I engage? Engage every individual. The clinical trial site team is composed of many different stakeholders or personnel. Each member of that team has their own way of communicating, their favorites and preferences. Engaging successfully does not just mean connecting with people. It requires the personalization of the message and identification of the audience to ensure that every interaction is rewarding. How do I engage? It is essential that you are aware of the needs and challenges of your staff, and that this forms the basis for your engagement and communication. While the Principal Investigator in a large research center may be interested in updates on the therapy area, other site staff in a smaller center may want succinct information to allow them to stay abreast of applicable study changes. Engage sites based on what they do. Technology now allows us to trigger communication and establish interaction based on a person's actions. Your site staff’s usage and access to study tools can dictate your engagement strategy. The timing of your communication will also be important. Take into account different time zones. For example, while a message may be received well on the East Coast of the US at midday on a Wednesday, that same message would reach a European-based site after they’ve left for the day. Deliver success for your sites Knowledge management can bring sites success. In turn, success will bring motivation and drive the overall trial experience. Knowledge delivered at the right time in the engagement process is critical to a successful interaction. We are all good at creating a contact list or sending an email to the study group email, but this is not engagement. Engagement evolves from meaningful, personal communications with your team. While it's true that creating and sustaining a successful engagement strategy with your site staff is a lot harder than simply passing on information, it's key to building effective relationships that are crucial to your clinical trial success. What strategies have you seen for effective site staff engagement? Please email connectwithbrian@teckro.com, I'd love to hear your thoughts.
Blog
Oct 08, 2019
On a Mission to Modernize and Simplify Clinical Research 
In the world of design, simplicity is achieved by removing, rather than adding more. The most elegant designs are those where there is nothing left to take away. Yet, a simple design is anything but simple to achieve as it requires a deep understanding of the purpose for the design.  At Teckro, we are applying the same concept of design simplicity to address today’s broken clinical trial process. You don’t have to look hard to find staggering evidence of how the industry is in desperate need of simplification. While there is nearly a three-fold increase in the number of trials just in the last 10 years, the practices to run a clinical trial haven’t changed in decades.  And while there are more trials, success rates aren’t necessarily improving. It is estimated that less than half of Phase II trials have successful outcomes. Of course, there are safety and scientific reasons that studies fail, which is the nature of clinical research. Our concerns are the avoidable blocking factors that stand in the way of success, such as too much paper, inconsistent communication, or a general lack of visibility into what’s going on with the study.  In today’s digital world, it is hard to believe that the primary interface for most clinical trials is a paper document or a PDF file that resides somewhere on a portal. Not only are these solutions impractical, they increase, rather than decrease, the interaction cost for busy site staff to fully engage with the trial. Unfortunately, the statistics reflect this with 40% of sites under recruiting and 80% of clinical trials failing to meet recruitment timelines.  Physicians have only minutes with each patient, and even less time to consider eligibility for a clinical trial. Yet, the protocol is rarely available where the patient is. These challenges of time and access extend beyond patient recruitment to all aspects of clinical trial compliance, including patient safety and toxicity management. The need for instant, reliable answers is paramount. At Teckro, we asked ourselves what can we take away to simplify clinical research? We’ve identified three key areas where we can modernize and simplify how things are done today so we can help protect patient safety and improve study quality:  Make all current, approved study information securely accessible in seconds anytime, anywhere through a smartphone or web-enabled device.  Create a secure, real-time digital connection to every stakeholder so that critical information and communication can be targeted to the right people at the right time.  Provide actionable insights into study performance so that issues can be detected sooner and proactively addressed.  By tackling these three areas, Teckro is bridging the gap between site staff and sponsors with a single platform. The focus is simplification. To design the most useful solutions possible, we spend countless hours of research and interviews to really understand the jobs that our users need to do.  Out of this deep understanding, we have solutions that make the process more transparent. Depending on the user, the questions are different. Site staff need quick answers to whether patients are eligible for a study, how to conduct a procedure, or how to manage an adverse event. Sponsors want to understand site engagement and whether there are early indications of any issues with the protocol or patient safety. All study stakeholders can use Teckro to find an answer to their study questions. Our corporate video provides a good explanation. By tackling complexity in clinical research, more sites will be engaged, their participation will be more successful, and they will extend access to more patients around the world. What do you think about our approach to simplicity? I would love to hear your thoughts. Please email me at connectwithgary@teckro.com. 
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Jul 23, 2019
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Press Release
Jul 18, 2019
Teckro Announces 45 High Tech Jobs in Dublin
Main expansion is in Dublin-based Engineering Excellence Hub as Teckro heavily invests in product development to simplify and modernize clinical research  LIMERICK, IRELAND - Teckro, the indigenous Irish firm transforming clinical trials for leading pharmaceutical and emerging biotech companies today officially announced 45 high-end tech jobs for Dublin, representing more than 100% growth in staff here. The company currently has more than 110 employees with offices in Limerick and the US, but the majority of the new roles will be in the company’s Engineering Excellence Hub in Dublin’s Silicon Docks. The technical jobs will span functions across engineering, data science, design and usability, quality and product management. The staff expansion follows the recent appointments of Anita Callan as Vice President of Product, most recently from Aer Lingus, and Neil Flanagan as Vice President of Engineering, previously with Munich Re to Teckro’s leadership team. Speaking at the announcement CEO and Co-Founder Gary Hughes said, “Although technology has revolutionized so many industries, the experience of participating in a clinical trial if you are a doctor, research nurse or patient has not changed in the last two decades. The industry still heavily relies on paper and inefficient processes. At Teckro, we are on a mission to simplify the process and make clinical trials more accessible for everyone involved. We are looking for more talented people, especially in technical roles, to join us and make an impact.”  The company, founded in 2015 by brothers Gary and Nigel Hughes and CTO Jacek Skrzypiec, is currently in scale out mode. This is the second startup founded in Ireland by the Hughes brothers and Skrzypiec, whose previous business, Firecrest Clinical, was sold to Nasdaq-listed clinical research giant ICON in 2011. Teckro provides solutions to simplify and modernize clinical research for leading pharmaceutical and biotech companies, currently managing more than 100 clinical trials and actively used by more than 11,800 study sites worldwide. Earlier this year the company announced a Series C funding round from major US venture capital firms, including Founders Fund, Bill Maris’ Section 32, Borealis Ventures, Northpond Ventures and Sands Capital Ventures that brought its total funding to $43 million and making it one of the fastest growing venture-backed companies developing product in Ireland. Minister for Business, Enterprise and Innovation Heather Humphreys welcomed the jobs saying, “It’s great to see an Irish company based in Dublin and Limerick succeed and grow internationally, especially one with a mission that will ultimately benefit patients and healthcare professionals in research to address global health problems. These 45 new tech jobs will play an important role for Teckro to deliver solutions from Ireland that will improve the clinical trial process throughout the world. This is another great example of how our SMEs are investing in new technologies, which is an important element in our Future Jobs Ireland strategy.” About Teckro Teckro clinical trial software transforms the study protocol into actionable data for everyone – research staff, CROs and sponsors. Global pharmaceuticals and emerging biotechs alike digitize their clinical trials with Teckro. Headquartered in Ireland, Teckro has locations across Europe and the United States. Visit www.teckro.com for more information.
Press Coverage
Jul 18, 2019
Teckro Announces 45 Dublin Jobs as it Expands Engineering Hub
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Jul 05, 2019
Teckro CEO Gary Hughes’ Appetite For Disruption
Press Release
Jul 02, 2019
Teckro Expands Leadership Team
Founders Fund-backed company announces 5 senior hires with domain experience from publicly traded companies including Veeva Systems, Salesforce, ICON and Munich Re LIMERICK, IRELAND - Teckro, the company transforming clinical trials for the world’s leading pharmaceutical and emerging biotech firms, today announced five significant appointments to its leadership team as it executes aggressive go-to-market and product strategies. The hires follow Teckro’s Series C funding announcement in February, featuring investment from major US venture capital firms, including Founders Fund, Bill Maris’ Section 32, Borealis Ventures, Northpond Ventures and Sands Capital Ventures. To date, Teckro has raised $43 million, with the latest round of $25 million earmarked for scale-up activities to accelerate growth and meet a sharp increase in demand from pharmaceutical and biotech companies looking to simplify and modernize clinical trials with Teckro. Speaking on the appointments to the leadership team, Teckro CEO and co-founder Gary Hughes said, “Every clinical trial starts with a question. At Teckro, we believe that finding answers should be simple for all study stakeholders anytime, anywhere. The new leadership appointments are important as we continue to expand our product and commercial strategies. I am delighted to have this group of seasoned professionals from established public companies join Teckro on our mission to simplify and modernize clinical research.” Teckro’s new hires bring vast experience across domains, including medical affairs, commercial and engineering: Professor Brendan Buckley, Chief Medical Officer With more than four decades in academic clinical practice, Buckley brings extensive experience as a senior clinical investigator. Buckley has served in several independent regulatory roles in the European Medicines Agency (EMA) and the Irish competent authority. With more than 150 scientific papers published, Buckley also authored the recent opinion-leading book Re-Engineering Clinical Trials. From 2011-2017, Buckley served as Chief Medical Officer and Executive Vice President of ICON, one of the world’s largest clinical research organizations. Kelly Brown, Chief Marketing Officer and Sandra Blaser, VP of Services & Success Also joining Teckro from global life science software giant Veeva Systems are Kelly Brown and Sandra Blaser as Chief Marketing Officer and Vice President of Services & Success, respectively. Brown, previously VP of Marketing in Europe at Veeva, brings more than a decade of experience in the technology sector, including an 11-year stint at EMC (now Dell EMC). Early in her career, Blaser was one of first European employees at Salesforce and served as its first-ever customer success manager in the region. Before joining Teckro, Blaser spent more than five years at Veeva where she managed the customer success team in Europe. Anita Callan, VP of Product and Neil Flanagan, VP of Engineering On the technical side, Teckro bolsters its team with two seasoned professionals, Anita Callan and Neil Flanagan, who collectively will use their vast experience to ensure Teckro’s products meet and exceed customer expectations. Callan joins as Vice President of Product, most recently working at Aer Lingus where she held product and content strategy positions. Flanagan joins as Teckro Vice President of Engineering with extensive experience in building and running highly scalable technology teams. Prior to Teckro, Flanagan most recently was Head of Digital Operations at Munich Re, one of the world’s largest reinsurance companies. Collectively, these new leaders are instrumental in Teckro’s mission to simplify and modernize clinical research. Demand is strong as the number of trials on Teckro has more than tripled over the past couple of years. Today, more than active 11,800 study sites use Teckro in all major countries around the world. Equally important, user adoption of Teckro is high, with more than 90% of registered users active on the platform. About Teckro Teckro clinical trial software transforms the study protocol into actionable data for everyone – research staff, CROs and sponsors. Global pharmaceuticals and emerging biotechs alike digitize their clinical trials with Teckro. Headquartered in Ireland, Teckro has locations across Europe and the United States. Visit www.teckro.com for more information.
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Jul 02, 2019
Teckro Hiring Spree Nets Ex-Icon CMO
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Apr 01, 2019
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Press Release
Feb 14, 2019
Teckro Raises $25 Million Series C Round to Speed up Clinical Trials
Teckro is a technology platform that makes the conduct of clinical trials simple, more transparent and more inclusive for doctors, research nurses and patients  Teckro’s total funding rises to $43 million to date from the likes of Northpond Ventures, Founders Fund and Bill Maris’ Section 32  LIMERICK, IRELAND - Teckro has raised a fresh round of funding to accelerate its international expansion and product development. The $25 million Series C round was led by Northpond Ventures with participation from Founders Fund, Sands Capital Ventures, Bill Maris’ Section 32 venture fund, and Borealis Ventures. Teckro’s total funding now stands at $43 million. The company provides technology to improve the speed and accuracy of clinical trials, working with the top pharmaceutical and biotech companies globally. Teckro has grown rapidly since it was founded by brothers Gary and Nigel Hughes and Jacek Skrzypiec in 2015. The founders sold their previous company, Firecrest, to global clinical research giant ICON plc in 2011. Teckro is used in clinical research sites around the world in all major countries. There has been a 240% increase in the number of clinical trials on the Teckro platform over the past 12 months. The company employs more than 100 staff across its three global bases, including its global headquarters in Limerick, Ireland, its engineering hub in Dublin, Ireland and its US office in Nashville, Tennessee.  Speaking on the funding announcement, CEO and co-founder Gary Hughes said the company will use the Series C round to further the company’s mission to deliver solutions that deliver meaningfully impact and improve processes for all stakeholders involved in clinical trials. “Despite all the talk of digital transformation, the actual experience of participating in a clinical trial if you are a doctor, research nurse or patient has changed little in the last 20 years. The industry still relies heavily on paper, on working off retrospective data, and there is still an over-reliance on sending CRAs to busy research sites. This approach, together with the plethora of point solutions that get ‘bolted on’, only adds to the complexity and disjointed experience of research sites and patients. Our vision is to be at the center of all site and patient interactions in a clinical trial. We are building a new digital infrastructure and toolset for clinical research that makes the conduct of trials simpler, more transparent and more inclusive. Ultimately Teckro is about ensuring that effective drugs are efficiently and effectively moved from the lab to the patient so that lives be saved.” Michael Rubin, M.D., Ph.D., Founder & CEO of Northpond Ventures commented: “Teckro is building a digital infrastructure that can transform how clinical trials are conducted. We are excited by the team and what they have achieved to date and look forward to supporting them on this important mission.” About Teckro Teckro clinical trial software transforms the study protocol into actionable data for everyone – research staff, CROs and sponsors. Global pharmaceuticals and emerging biotechs alike digitize their clinical trials with Teckro. Headquartered in Ireland, Teckro has locations across Europe and the United States. Visit www.teckro.com for more information.
Press Coverage
Feb 14, 2019
Limerick-based Teckro Raises $25m in Funding